Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-01-02 @ 12:50 PM
Study NCT ID:
NCT02778750
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Of The Pan-microbiome and Host Immune Response in CF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Oral Inflammatory markers', 'timeFrame': 'Baseline, 6 Months'}, {'measure': 'Changes in Sputum Inflammatory Markers measured using research bronchoscopy', 'timeFrame': 'Baseline, 6 Months'}, {'measure': 'Changes in Gut Microbiome', 'timeFrame': 'Baseline, 6 Months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis (CF)'], 'conditions': ['Cystic Fibrosis (CF)']}, 'descriptionModule': {'briefSummary': 'Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic Fibrosis patients to explore microbiome features that are associated with an inflammatory phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome are associated with host inflammatory responses.\n\nWhile chronic and polymicrobial airway colonization are commonly recognized in cystic fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be three approaches to understanding inflammatory responses; 1) a longitudinal assessment of temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison of the regional differences in airway microbiome between lung segments with more versus less disease; 3) evaluation of functional aspects of the lung microbiome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Multicenter study to create a longitudinal cohort of adult CF subjects recruited from NYU and Columbia. A subgroup of subjects will be selected for a more invasive assessment of the lung microbiome with research bronchoscopy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CF diagnosis\n* able to produce sputum\n* no recent (one month) exacerbation defined as physician treatment with antibiotics for ≥ 7days\n* FEV1 ≥ 30% of predicted.\n\nExclusion Criteria:\n\n* Initiation of any new chronic therapy (e.g., ibuprofen, aerosolized rhDNase, hypertonic saline, azithromycin, tobramycin inhalation solution, aztreonam inhalation solution, ivacaftor) within 8 weeks prior to enrolment\n* introduction of vitamins or proton pump inhibitors within 8 weeks prior to enrolment\n* use of new investigational therapy within 4 weeks\n* current smoker; use of oral corticosteroids\n* Initiation of treatment or change in regimen for allergic bronchopulmonary aspergillosis or nontuberculous mycobacteria within 8 weeks.\n* liver enzymes \\> 3 times the upper limit\n* pregnancy\n\nAdditional Exclusion Criteria for Bronchoscopy Subgroup (Aims 2 and 3):\n\n* FEV1 \\< 50% of predicted.\n* Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.\n* Significant renal disease (Creatinine Clearance \\< 30%).\n* Severe malnutrition (BMI \\<18kg/m2)'}, 'identificationModule': {'nctId': 'NCT02778750', 'briefTitle': 'Evaluation Of The Pan-microbiome and Host Immune Response in CF', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Evaluation Of The Pan-microbiome and Host Immune Response in Cystic Fibrosis (CF)', 'orgStudyIdInfo': {'id': '14-01692'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stable Group', 'interventionNames': ['Procedure: Two-Bronchoscope Technique']}, {'label': 'Rapid Decliner Group', 'interventionNames': ['Procedure: Two-Bronchoscope Technique']}], 'interventions': [{'name': 'Two-Bronchoscope Technique', 'type': 'PROCEDURE', 'description': 'Used to validate the use of sputum to sample the lower airway microbiome', 'armGroupLabels': ['Rapid Decliner Group', 'Stable Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Leopoldo Segal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}